Will GSK lupus drug be approved? AP report notes concerns

A report from The Associated Press on Friday raises questions about whether the new drug Benlysta developed by GlaxoSmithKline (NYSE: GSK) and Human Genome Sciences (Nasdaq: HGSI) will be approved.

Federal health officials say the first new drug developed to treat lupus in decades relieves disease symptoms, but appears less effective in patients from certain racial and ethnic backgrounds, the AP noted

If approved, the drug would be the first new lupus treatment in about 50 years.

However, FDA reviewers are concerned that African American patients appeared to fare worse when taking the drug. Reviewers also note that the drug’s benefit appeared greater among patients from Latin America, compared with those from the U.S. and Canada.

An FDA panel will vote on the drug’s effectiveness at a public meeting next week.

For earlier LTW coverage of the drug and the review, read here.

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